[Federal Register Volume 59, Number 75 (Tuesday, April 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9350]


[[Page Unknown]]

[Federal Register: April 19, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0063]

 

Medtronic, Inc.; Premarket Approval of the Medtronic 
Transvene Lead System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
approval of the application by Medtronic, Inc., Minneapolis, MN, for 
premarket approval, under section 515 of the Federal Food, Drug, and 
Cosmetic Act (the act), of the Medtronic Transvene 
Lead System. After reviewing the recommendation of the Circulatory 
System Devices Panel, FDA's Center for Devices and Radiological Health 
(CDRH) notified the applicant, by letter of December 9, 1993, of the 
approval of the application.

DATES: Petitions for administrative review by May 19, 1994.

ADDRESSES: Written requests for copies of the summary of safety and 
effectiveness data and petitions for administrative review to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Doris J. Terry, Center for Devices and 
Radiological Health (HFZ-450), Food and Drug Administration, 1390 
Piccard Dr., Rockville, MD 20850, 301-594-1523.

SUPPLEMENTARY INFORMATION: On April 1, 1992, Medtronic, Inc., 
Minneapolis, MN, 55432, submitted to CDRH an application for premarket 
approval of the Medtronic Transvene Lead System. 
The device is a transvenous defibrillation lead system and is intended 
for single long-term use, and each lead is designed to be used only 
with a compatible Medtronic, Inc., implantable tachyarrhythmia control 
device along with at least one other Medtronic, Inc., defibrillator 
lead. The lead system has application where implantable tachyarrhythmia 
cardioversion or defibrillation systems are indicated. Current medical 
research indicates that such patients should: (1) Have survived at 
least one episode of a cardiac arrest, presumably due to a ventricular 
tachyarrhythmia as evidenced by resuscitation using a transthoracic 
defibrillator. The ventricular tachyarrhythmia should not have been 
caused by an acute myocardial infarction; or (2) in the absence of a 
prior cardiac arrest, have poorly tolerated sustained ventricular 
tachycardia and/or ventricular fibrillation, which occurs 
spontaneously, or can be induced, despite the best antiarrhythmic drug 
therapy.
    The natural history of patients with hemodynamically stable 
sustained ventricular tachycardia is not well defined. While this 
patient population was included in the Transvene lead 
clinical study, no conclusions were drawn from the data obtained on 
this specific patient group.
    Prior to a Transvene implant, it is strongly recommended 
that patients undergo a complete cardiac evaluation, which should 
include extensive electrophysiologic testing. Also, extensive 
electrophysiologic evaluation and testing of the safety and efficacy of 
the proposed pacing, cardioversion, or defibrillation therapies are 
recommended during and after the implantation of the 
Transvene system.
    On August 2, 1993, the Circulatory System Devices Panel of the 
Medical Devices Advisory Committee, an FDA advisory committee, reviewed 
and recommended approval of the application. On December 9, 1993, CDRH 
approved the application by a letter to the applicant from the Acting 
Director of the Office of Device Evaluation, CDRH.
    A summary of the safety and effectiveness data on which CDRH based 
its approval is on file in the Dockets Management Branch (address 
above) and is available from that office upon written request. Requests 
should be identified with the name of the device and the docket number 
found in brackets in the heading of this document.

Opportunity for Administrative Review

    Section 515(d)(3) of the act (21 U.S.C. 360e(d)(3)) authorizes any 
interested person to petition, under section 515(g) of the act (21 
U.S.C. 360e(g)), for administrative review of CDRH's decision to 
approve this application. A petitioner may request either a formal 
hearing under part 12 (21 CFR part 12) of FDA's administrative 
practices and procedures regulations or a review of the application and 
CDRH's action by an independent advisory committee of experts. A 
petition is to be in the form of a petition for reconsideration under 
Sec. 10.33(b) (21 CFR 10.33(b)). A petitioner shall identify the form 
of review requested (hearing or independent advisory committee) and 
shall submit with the petition supporting data and information showing 
that there is a genuine and substantial issue of material fact for 
resolution through administrative review. After reviewing the petition, 
FDA will decide whether to grant or deny the petition and will publish 
a notice of its decision in the Federal Register. If FDA grants the 
petition, the notice will state the issue to be reviewed, the form of 
review to be used, the persons who may participate in the review, the 
time and place where the review will occur, and other details.
    Petitioners may, at any time on or before May 19, 1994, file with 
the Dockets Management Branch (address above) two copies of each 
petition and supporting data and information, identified with the name 
of the device and the docket number found in brackets in the heading of 
this document. Received petitions may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
    This notice is issued under the Federal Food, Drug, and Cosmetic 
Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under 
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10) 
and redelegated to the Center for Devices and Radiological Health (21 
CFR 5.53).

    Dated: April 5, 1994.
 Joseph A. Levitt,
 Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 94-9350 Filed 4-18-94; 8:45 am]
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